510(k) · Cleared
Recalled · Class I · 2024BioZorb Marker
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Focal Therapeutics · NEU Marker, Radiographic, Implantable
Cleared on Jun 29, 2015 as substantially equivalent to K102506 (Cortex Manufacturing, Inc., 2011) and 2 other predicates after a 203-day review. Its family tree reaches back 5 generations to 2001. 2 of the 20 devices in its family, counting itself, have a Class I recall. 7 later devices descend from it. It has been recalled once, including a Class I recall.
- Decided
- Jun 29, 2015
- Review
- 203 days
- Class
- Class II
- Product code
- NEU
- Recalls
- 1 (1 Class I)
- Predicates
- 3
Its longest line of descent runs back 5 generations to K001807 (2001). 12 ancestors in all. 7 later devices descend from it, 5 citing it directly. 2 of the 20 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK001807 Tissue MarkerAdvanced Uroscience, Inc. · 2001
- 4 generations backK032347 Biomarc Tissue MarkerCarbon Medical Technologies, Inc. · 2003
- 3 generations backK042296 Biomarc Preloaded Tissue Marker DeviceCarbon Medical Technologies, Inc. · 2004
- 2 generations backK072913 Securmark Biopsy Site Identification SystemSuros Surgical Systems, Inc. A Hologic Company · 2008
- 1 generation backK113202 Tissue MarkerFocal Therapeutics · 2012
- This deviceK143484 BioZorb MarkerFocal Therapeutics · 2015
- Descendant · cites it directly · 5 of its ownK152070 BioZorb LP MarkerFocal Therapeutics · 2015 · Recalled (Class I)
- Descendant · cites it directly · 1 of its ownK180640 SmartClip Soft Tissue MarkerElucent Medical, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK233639 SmartClip Secure Soft Tissue MarkerElucent Medical, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK192371 BioZorb SP MarkerFocal Therapeutics · 2019
- Descendant · cites it directly · 0 of its ownK180027 ACCUSYTE 3D Fiducial MarkerRadiation Products, LLC · 2018
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K152070 BioZorb LP Markercites it directly · 2015
Most influential descendants
Showing 5 of 7 · See all- K152070BioZorb LP MarkerFocal Therapeutics · 2015 · cites it directly5descendants
- K180640SmartClip Soft Tissue MarkerElucent Medical, Inc. · 2018 · cites it directly1descendant
- K233639SmartClip Secure Soft Tissue MarkerElucent Medical, Inc. · 2024 · 2 generations on0descendants
- K192371BioZorb SP MarkerFocal Therapeutics · 2019 · cites it directly0descendants
- K180027ACCUSYTE 3D Fiducial MarkerRadiation Products, LLC · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K001807 | Tissue Marker | Advanced Uroscience, Inc. | 2001 | — |
| −4 | K032347 | Biomarc Tissue Marker | Carbon Medical Technologies, Inc. | 2003 | — |
| −3 | K042296 | Biomarc Preloaded Tissue Marker Device | Carbon Medical Technologies, Inc. | 2004 | — |
| −2 | K072913 | Securmark Biopsy Site Identification System | Suros Surgical Systems, Inc. A Hologic Company | 2008 | — |
| −1 | K113202 | Tissue Marker | Focal Therapeutics | 2012 | — |
| 0 (this device) | K143484 | BioZorb Marker | Focal Therapeutics | 2015 | — |
| +1 | K152070 | BioZorb LP Marker | Focal Therapeutics | 2015 | Class I |
| +1 | K180640 | SmartClip Soft Tissue Marker | Elucent Medical, Inc. | 2018 | — |
| +2 | K233639 | SmartClip Secure Soft Tissue Marker | Elucent Medical, Inc. | 2024 | — |
| +1 | K192371 | BioZorb SP Marker | Focal Therapeutics | 2019 | — |
| +1 | K180027 | ACCUSYTE 3D Fiducial Marker | Radiation Products, LLC | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2007 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 1 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
2 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NEU device
- #1 K240042 MOLLI 2 Systemscore 14.4 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K102506 | Mixed Media MarkerSummary page 4…lip, 21 CFR, 878.4300, 892.5050 NAME: DEVICE Class II CLASSIFICATION: PRODUCT CODE NEU PREDICATE DEVICES: Mixed Media Marker (K102506) Civco Suture-type Marker [reference predicate] (K071614) Focal Therapeutics BioZorb… | 2011 |
| * | K071614 | Fiducial MarkersSummary page 4…CLASSIFICATION: PRODUCT CODE NEU PREDICATE DEVICES: Mixed Media Marker (K102506) Civco Suture-type Marker [reference predicate] (K071614) Focal Therapeutics BioZorb Tissue Marker (K113202) Substantially Equivalent To: The BioZorb Marker is su… | 2007 |
| * | K113202 | Tissue MarkerSummary page 4…xed Media Marker (K102506) Civco Suture-type Marker [reference predicate] (K071614) Focal Therapeutics BioZorb Tissue Marker (K113202) Substantially Equivalent To: The BioZorb Marker is substantially equivalent in intended use, principal of operation and techno… | 2012 |
What descends from it? (7)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 10, 2024 | Class I | Z-0328-2025 | Device Design | Firm received reports of adverse events/complications that include serious injuries, such as pain, infection, rash, device migration, device erosion, seroma, and discomfort. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K152070BioZorb LP MarkerFocal Therapeutics · 2015 · Cites it directly · ◆ in the 2015 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 14 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K152070 (Focal Therapeutics, 2015) has gone furthest, with 5 descendants of its own.
- 3 other devices also cite its predicate K102506.
How does its category compare?
All NEU devicesNEU Marker, Radiographic, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · NEU
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NEU
99in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NEU
2in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NEU
411in 2025
MAUDE reports naming product code NEU, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 94 | 0 | 5 |
| 2008 | 7 | 107 | 0 | 5 |
| 2009 | 4 | 70 | 0 | 30 |
| 2010 | 5 | 69 | 0 | 12 |
| 2011 | 3 | 145 | 1 | 18 |
| 2012 | 3 | 120 | 0 | 54 |
| 2013 | 7 | 49 | 0 | 60 |
| 2014 | 3 | 48 | 0 | 38 |
| 2015 | 7 | 111 | 0 | 120 |
| 2016 | 2 | — | 0 | 56 |
| 2017 | 4 | 115 | 1 | 69 |
| 2018 | 8 | 89 | 0 | 66 |
| 2019 | 5 | 149 | 0 | 58 |
| 2020 | 3 | 169 | 0 | 45 |
| 2021 | 3 | 46 | 0 | 82 |
| 2022 | 2 | — | 1 | 100 |
| 2023 | 4 | 136 | 0 | 142 |
| 2024 | 10 | 267 | 2 (1) | 247 |
| 2025 | 5 | 99 | 2 | 411 |
| 2026 | 1 | — | 2 | — |
What is it indicated for?
The BioZorb Marker is indicated for radiographic marking of sites in soft tissue.
In addition, the Marker is indicated in situations where the soft tissue site needs to be marked for future medical procedures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K143484 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143484: BioZorb Marker.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143484
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026